Transfusion of Fresh Frozen Plasma in Non-bleeding Intensive Care Unit (ICU) Patients

Not Applicable

Completed

• Conditions: Blood Coagulation Disorders; Hemorrhage
• Interventions: Other: omitting FFP transfusion before an intervention

• Registration Number: NCT01143909
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

With the aim to restrict inappropriate fresh frozen plasma (FFP) transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of intensive care (ICU) patients undergoing an invasive procedure. The objective is to assess the effectiveness and costs of omitting prophylactic FFP transfusion compared to current practice of prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy.

Detailed Description

Rationale: Fresh frozen plasma (FFP) is an effective therapy to correct for a deficiency of multiple coagulation factors during bleeding. In past years, use of FFP has increased, in particular in patients on the Intensive Care Unit (ICU), and has expanded to include prophylactic use in patients with a coagulopathy prior to undergoing an invasive procedure. Retrospective studies suggest that prophylactic use of FFP does not prevent bleeding, but carries the risk of transfusion-related morbidity. However, up to 50% of FFP is administered to non-bleeding ICU patients.

Objective: With the aim to restrict inappropriate FFP transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of ICU patients with a coagulopathy undergoing an invasive procedure. The objective is to assess the effectiveness and costs of prophylactic FFP transfusion (current practice) compared to no prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy, prior to undergoing an invasive procedure (e.g. placement of central venous catheter, tracheostomy, chest tube).

Study design: Prospective, multicentre, randomized, open-label, blinded end point evaluation (PROBE) design.

Study Timeline

• Study Start: 2010-05
• Status Verified: 2010-06
• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-14
• Study First Posted: 2010-06-15
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-14
• Last Update Posted: 2013-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• 18 years and older
• INR >1.5 and <3.0
• undergoing invasive procedure (insertion of a central venous catheter, a chest drain, percutaneous tracheostomy)

Exclusion Criteria

• clinically overt bleeding at the time of the procedure (excludes minor epistaxis, minor gum bleeding, microscopic hematuria, superficial bruises, or normal menses)
• thrombocytopenia of < 30 x 109/L.
• use of abciximab, tirofiban, ticlopidine or activated protein C
• use of heparin < 1 hour prior to the procedure, or low molecular weight heparin in therapeutic doses < 12 hours prior to procedure
• history of congenital or acquired coagulation factor deficiency or bleeding diathesis
• no informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No FFP transfusion prior to intervention	omitting FFP transfusion before an intervention	Patients with a coagulopathy (INR 1,5-3,0), who are randomized to omitting transfusion of fresh frozen plasma before they undergo an intervention.

Primary Outcome Measures

Name	Time	Method
Procedure-related relevant bleeding, occurring within 24 hours after the procedure.	24 hours after the procedure	Relevant bleeding will be defined using a validated tool for assessment of bleeding in the critically ill.; An assessment of bleeding will be standardized and performed by an independent research physician or intensivist blinded to the transfusion strategy 1 and 24 hours after the procedure and when clinically indicated.

Secondary Outcome Measures

Name	Time	Method
minor bleeding within 24 hours	within 24 hours of the procedure
onset of acute lung injury within 48 hours.	48 hours within the intervention	Lung injury will be evaluated by P/F ratio, change in ventilator settings, chest x-ray and Lung Injury Score.
effect of FFP transfusion on coagulation parameters	within 24 hours of transfusion of FFP	a range of coagulation parameters will be evaluated to assess efficacy of FFP transfusion in these patients
evaluation of costs	up to 28 days after inclusion	Evaluation of costs in the two different groups will be made. Length of stay, number of ventilation days, differences in medication use, all will be taken into account.

Trial Locations

Locations (4)

Diakonessenhuis; 🇳🇱 Utrecht, Netherlands

Academic Medical Centre - University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

Leids Universitair Medisch Centrum; 🇳🇱 Leiden, Netherlands

Ter Gooi Ziekenhuizen; 🇳🇱 Hilversum, Netherlands